Prophylactic and therapeutic treatment of alzheimer&#39;s disease using phytic acid and phytate to reduce amyloid beta plaque and tau protein

ABSTRACT

A composition and method for the treatment of Alzheimer&#39;s disease and related amyloid plaque development and reduction of amyloid plaque, amyloidosis and amyotrophic lateral sclerosis, includes an effective amount of a compound selected from the group consisting of phytic acid, a phytate salt, an isomer or hydrolysate of phytic acid or a phytate salt, or a mixture of any combination thereof, being administered to a person in an amount from about 0.5 grams to about 18.75 grams per day.

RELATED APPLICATIONS

This application is a continuation of application Ser. No. 17/064,536filed Oct. 6, 2020, which '536 application is a continuation ofapplication Ser. No. 12/661,964 filed Mar. 26, 2010, which '964application claims priority from provisional application No. 61/211,230filed Mar. 27, 2009 and provisional application No. 61/273,126, filedJul. 29, 2009 and claims benefit and priority under 35 U.S.C. § 119(e).These applications are incorporated by reference herein. The applicantclaims priority under 35 USC § 120 from the '536 and '964 applicationsherein.

All Patents, Scientific Articles, and other Documents mentioned hereinare incorporated by reference as if reproduced in full below.

FIELD OF THE INVENTION

This invention relates to the prophylactic and therapeutic treatment ofAlzheimer's Disease, herein-below identified as “AD”.

BACKGROUND OF THE INVENTION

Phytic acid, generally accepted as having the structuremyo-inositol-hexakis (dihydrogen phosphate), is a major component ofplant seeds, constituting 1-3% by weight of many cereals and oil seeds.Most wheat brans contain between 4 and 5% phytic acid. Phytic acid maybe prepared in pure form from various plant sources, such as wheat,corn, soybeans, sesame seeds, peanuts, lima beans, barley, oats, wildrice and sunflower seeds. It can be extracted with dilute hydrochloricacid at room temperature, precipitated with various reagents includingferric chloride, bicarbonates, potassium hydroxide, sodium hydroxide,ammonium hydroxide, calcium hydroxide, magnesium hydroxide or alcohol.It is then further purified by conventional chemical techniques.

When one or more of the acidic protons of the phosphate groups in phyticacid are replaced by a counterion, the compound is usually referred toas a phytate salt. The special name phytin is used for thecalcium-magnesium salt of phytate derived from plant seeds (a product ofCiba-Geigy). The present invention includes the use not only of phyticacid and phytate salts, but also various isomeric forms of phytic acidand phytate salts. While the Anderson structure for myo-inositol hexakisdihydrogen phosphate is the accepted structure for phytic acid, thepresent invention covers other isomers which have been previouslydescribed in the literature. These isomers include the cis, epi, allo,muco, neo, D-chiro, L-chiro, and scyllo configurations.

Also, while phytic acid contains six phosphate groups, when introducedinto the digestive tract of an animal, one or more of the phosphategroups may be hydrolyzed by the action of the digestive acids andenzymes. Therefore, the present invention includes the use ofhydrolysates of phytic acid and phytate salts wherein one or more of thephosphate groups have been removed.

The main uses of phytic acid include use as a food additive forpreservation of foods. Studies on the use of phytic acid as a foodadditive show that ingestion of large doses of phytic acid elicits nophysiological discomfort or symptoms of any toxicological action inhumans. See Starkenstein, Biochem. Z. 30: 56 (1911). Phytic acid and itsmetabolites are thus not believed to be toxic or highly reactive.

Phytic Acid is the 6 phosphates ester of inositol. Inositol, chemicallyhexahydroxycylohexane, is any of nine stereoisomeric alcohols thatclosely resemble glucose in structure. It is a constituent of many cellphosphoglycerides. Meso- or myo-inositol, named for its presence inmuscle tissue, is biologically the important isomer. Myo-inositol is theprecursor in the phosphatidylinositol cycle, a source of two secondmessengers (diacylglycerol and inositol triphosphate). Inositols andtheir phosphates lack a hydrolytically labile glycosidic linkage and arestable to degradative enzymes in vivo. They have been used in the stableinsulin mediators, inhibitors, and modulators. The phytic acid may be ina salt form, such as, for example, calcium magnesium phytate salt.

Two reports from Science Magazine of 3 Nov. 2006 support the importanceof reducing Abeta plaque production as a therapeutic goal. See Goedertand Spillantini “A Century of Alzheimer's Disease”, SCIENCE, Vol. 314, 3Nov. 2006, pp 779-781. See also Roberson and Mucke, “100 Years andCounting: Proposals for Defeating Alzheimer's Disease,” SCIENCE, Vol.314, 3 Nov. 2006, pp. 781-784.

U.S. Pat. No. 4,847,082 (referred to herein as the '082 patent) and U.S.Pat. No. 4,758,430 (referred to herein as the '430 patent) both toSabin, each of which is expressly incorporated herein by reference,disclose one embodiment for administration of phytic acid or equivalentphytate salt, isomer or hydrolysate as about one-half to three grams perkilogram of body weight orally per day.

Scyllo inositol, has been shown to prevent and reverse Alzheimer'sDisease in a transgenic mouse model of Alzheimer's Disease (See NatureMedicine article) (See “A Sweet Solution to Alzheimer's Disease”) (See“ALD103 May Prevent and Reverse Alzheimer's Disease”) (See“Scyllo-Inositol Appears Promising for Alzheimer's Disease”).

Scyllo inositol also inhibits and blocks the aggregation of amyloid-Bpeptide (AB) in these same transgenic Alzheimer Disease mouse studies.The '082 patent discloses scyllo inositol as an isomeric form of phyticacid. Since the '082 and '430 patents disclose a minimum oral dose ofabout a half a gram per kilogram/body weight per day, a 75 kilogram ADpatient, would take 37.5 grams of scyllo inositol orally per day. Thisdose is burdensome. Additionally, phytate in food has been successfullyconsumed at this dose and higher.

Scyllo inositol is also disclosed in U.S. patent application Ser. No.10/787,621 of McLaurin. This application discloses a litany of compoundsfor the treatment of disorders of protein aggregation, the mostpreferred compound of which is scyllo inositol.

SUMMARY OF THE INVENTION

Phytic acid, phytate salt, an isomer or hydrolysate of phytic acid or aphytate salt, or a mixture of any combination thereof is administered asa treatment for prevention and treatment of Alzheimer's disease and fortreatment of amyloidosis, aggregation of beta amyloid proteins and tauprotein in the brain.

An effective yet surprisingly low dose of the compounds phytic acid,phytate salt, an isomer or hydrolysate of phytic acid or a phytate salt,or a mixture of any combination thereof, except for scyllo inositol, areused for. as a prophylactic and therapeutic treatment for Alzheimer'sDisease. In a preferred embodiment, a dose of about 0.5 gram to about18.75 gms of phytic acid, phytate salt, an isomer or hydrolysate ofphytic acid or a phytate salt, or mixture of any combination thereof,except for scyllo inositol, are administered orally per day. This doseis 1/75th to one half (½) of the previously disclosed doses in the Sabinpatents cited above Phytate salt may also be administered as a capsule,and the calcium magnesium phytate salt, as packaged by many supplierssuch as Jarrow Formulations; is desirable.

Surprisingly, it has been discovered that very low doses of phytic acid,phytate salt, an isomer or hydrolysate of phytic acid or a phytate salt,or a mixture of any combination thereof are effective in the treatmentand prevention of aggregation of beta amyloid proteins as are commonlyseen in the brains of Alzheimer's patients. Treatment with such a lowdose of phytic acid, phytate salt, an isomer or hydrolysate of phyticacid or a phytate salt, or a mixture of any combination thereof preventsthe occurrence of potential side effects observed with high dosetreatments and allows for ease of administration to Alzheimer's patientswho may find it difficult to take high doses of the substance.Furthermore, it has been discovered that phytic acid, phytate salt, anisomer or hydrolysate of phytic acid or a phytate salt, or a mixture ofany combination thereof is much more effective than scyllo inositol andmyo inositol.

In one embodiment there is disclosed a composition for the treatment ofAlzheimer's disease and related amyloid plaque development by providinga person in need thereof with an effective amount of phytic acid,phytate salt, an isomer or hydrolysate of phytic acid or a phytate salt,or a mixture of any combination thereof.

In another embodiment, there is disclosed a method for the treatment ofAlzheimer's disease and the amyloid plaque protein aggregation by theoral administration of 0.5 to 18.75 grams of phytic acid, phytate salt,an isomer or hydrolysate of phytic acid or a phytate salt, or a mixtureof any combination thereof per day. Alternatively, the compounds of theinvention may be administered topically as a cream, ointment, gel andthe like, transdermally or intradermally.

For a better understanding of the present invention, together with otherand further objects, reference is made to the following description,taken in conjunction with the examples, and its scope will be pointedout in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The features and advantages of the present invention will becomeapparent from the following detailed description of a preferredembodiment thereof, taken in conjunction with the accompanying drawings,in which:

FIG. 1 is a chart of cell viability.

FIG. 2 is a chart of a bar graph of the percentage of H₂0₂, whereV=control and PA=phytic acid.

FIG. 3 is a chart of cell viability of scyllo inositol and myo inositol.

FIG. 4 is a chart of soluble amyloid beta 1-42/μg protein, phytic acidand a vehicle carrier.

FIG. 5 is a chart of soluble amyloid beta—40/μg protein, phytic acid anda vehicle carrier.

FIG. 6 is a chart of insoluble amyloid beta 1-42/μg protein, phytic acidand vehicle carrier.

DETAILED DESCRIPTION

The method according to the present invention comprises treating asubject, afflicted with Alzheimer's Disease, with a composition in whichthe active ingredient is phytic acid, a phytate salt, or an isomer orhydrolysate of phytic acid or phytate salt. By the term isomer as usedherein, it is intended to include the various conformations of phyticacid, as described hereinabove, and the corresponding conformations ofphytate salts. The term salts is broadly intended to cover any of thevarious salts formed by the replacement of any or all of the availableacidic protons of the phosphate groups with a counterion. The counterionmay be any pharmaceutically acceptable counterion such as sodium,magnesium, potassium, zinc, ferric, ferrous, and the like, includingorganic counterions such as quaternary ammonium ions and ions of organicbases.

The present invention also includes the hydrolysates of phytic acid andphytate salts wherein one or more of the phosphate groups have beenremoved. Once administered into the digestive tract, bloodstream, thephytic acid or phytate salt may be hydrolyzed by digestive, blood orcellular enzymes, thereby removing one or more of the phosphate groupson the cyclohexane ring. However, it is contemplated to be within thescope of the invention that these hydrolysates of phytic acid andphytate salts may also be administered directly to the subject andtherefore are within the scope of the present invention.

The hydrolysates of phytic acid and phytate salts may be prepared bypartial acid or basic hydrolysis or by hydrolysis using enzymes prior topreparation of dosage fauns for administration. Preferably, thehydrolysates will be made in vivo by coadministering with phytic acid orphytate salt an enzyme which hydrolyzes phosphate groups, such as3-phytase, 6-phytase or acid phosphatase.

The phytic acid or phytate salt may be absorbed into or adsorbed onto asolid carrier to facilitate pharmaceutical administration. For example,phytic acid may be formulated into a starch powder by spray drying orvacuum drying an aqueous mixture of phytic acid and dextrin.

The preferred compositions for administration, particularly in oraldosage form, are the mono-, di-potassium phytate salts and mixturesthereof which may be prepared from commercially and readily availablesodium phytate by initially removing the sodium using ion exchangechromatography on a suitable resin, such as Dowex beads. The free phyticacid may then be treated with potassium hydroxide to convert to themono- and di-potassium phytate salt.

The preferred method of administration of the compositions according tothe present invention is through oral administration in liquid or tabletform. As described hereinabove, the compositions may be administered aspharmaceutically acceptable salts such as salts with alkali metalcations (sodium, potassium, lithium), ammonium salts and salts withorganic bases such as piperidine, triethanolamine,diethylaminoethylamine salts, and the like.

In addition to the active ingredients, the composition may also containan effective proportion, usually from 0.001 to 0.1% weight by volume, ofa pharmaceutically acceptable preservative or sterilizing agent such ascetyl pyridinium chloride, tetradecyltrimethyl ammonium bromide(commercially known as Centramide), benzyl dimethyl[2-(2-)p-(1,1,3,3-tetramethyl butyl)) phenoxy) ethoxy] ammonium chloride(known commercially as Benzethonium Chloride) andmyristyl-gamma-picolinium chloride.

The pharmaceutical composition may also contain conventional excipients,e.g., sodium chloride, dextrose, mannitol, and buffers such as sodiumdihydrogen ortho phosphate, disodium hydrogen phosphate, sodiumcitrate/citric acid, and boric acid/sodium borate. The proportion andconcentration of excipients and buffers may be varied within fairly wideranges, providing the resulting solution is stable and nonirritatingwhen administered. The preferred method of administration is by oraladministration as a solid compound. The composition may be prepared inthe conventional manner as tablets, pills or powders, using conventionalcarriers.

The phytic acid may be combined with other inactive substances as areknown in the pharmaceutical arts such as, for example, lactates,silicates, and magnesium stearate, as well as with other activesubstances, such as pharmaceutical drugs and vitamins, etc.

For oral administration, in a preferred embodiment, the activeingredient of the composition will also contain an enzyme such as3-phytase (EC 3.1.38), 6-phytase (EC 3.1.3.26) or acid phosphatasewhich, when exposed to the digestive tract, will assist in hydrolyzingone or more of the phosphate groups from the active ingredient. Sincephytic acid or phytate salts are not naturally present in animals, thedigestive enzymes in animals are believed to be insufficient tocompletely hydrolyze the phosphate groups. Therefore, to enhance thehydrolysis of the phosphate groups in an animal or man, it is preferredthat the active ingredient be administered with one or more of theaforementioned enzymes, with the preferred enzyme being 3-phytase (EC3.1.38).

The phytic acid, phytate salt, an isomer or hydrolysate of phytic acidor a phytate salt, or a mixture of any combination thereof can beadministered in any manner as known in the art. In one embodiment thephytic acid is administered orally in encapsulated form. The oraladministration can be in the form of a capsule, quick dissolve tablet,table, or other form as known in the art. The dosage of phytic acid isan amount that is effective for the disease state of the Alzheimer'spatient and an amount effective as a prophylactic treatment forprevention of Alzheimer's disease. In one embodiment the dosage is fromorally about 0.5 g to about 18.75 g of phytic acid, phytate salt, anisomer or hydrolysate of phytic acid or a phytate salt, or a mixture ofany combination thereof per day.

The present invention can be better understood by reference to thefollowing examples. The following examples illustrate the presentinvention and are not intended to limit the invention or its scope inany manner.

EXAMPLES

The Applicant tested compounds disclosed in the above referenced patentsof Sabin using well established standard routine testing, as known inthe art, at Oregon Science and Health University in an in-vitrochallenge test.

The Applicant submits two pages of the data of these in vitro tests. Inthe first test, phytic acid attenuates APP CTF-induced neurotoxicity.APP is a precursor/source to beta amyloid plaque and is considered bymany to be a “bad actor”, “cause”, of Alzheimer's Disease. See DDN BENCHPRESS. Neither scyllo inositol nor myo inositol previously used by Baraket al, “inositol treatment of Alzheimer's disease: a double blind,cross-over placebo controlled trial”, Prog. Neuro-Psychopharmacol. &Biol. Psychiatry., 20 (4): 729-735, 1996 attenuated APP CTF-inducedneurotoxicity. Phytic acid is shown to be active, while scyllo inositoland myo inositol are shown to be inactive. These surprising andunexpected results with phytic acid attenuating APP CTF-inducedneurotoxicity, while scyllo inositol and myo inositol fails in thesesame tests, suggests that phytic acid would be effective as a treatmentfor Alzheimer's Disease at a surprising, unexpected, non-obvious,severely reduced dose, as against the previously cited claimed dosagesin the Alzheimer's Treatment Patents, especially since phytic acidproved scyllo inositol inactive in this in vitro challenge test. Theseresults from this in vitro test demonstrate superiority over scylloinositol and myo-inositol; and demonstrate novelty and reduction topractice for the prophylactic and therapeutic treatment of Alzheimer'sdisease.

In vitro studies were conducted in MC65 cells, an established humanneuroblastoma line that conditionally expresses the first 17amino-terminal residues and the 99 carboxy-terminal residues of amyloidprecursor protein (APP CTF). Detectable APP CTF expression occurs within3-4 h of tetracycline withdrawal, appearance of aggregates and initiallosses of culture viability occurs at about 2 days and near completedeath occurs by approximately 3 days.

Phytic Acid Attenuates APP CTF-induced Neurotoxicity

Phytic acid protected the cells from APP CTF-induced death in aconcentration dependent manner with an EC₅₀ concentration ofapproximately 100 μM and concentrations of 200 μM and higher providingnear complete protection from cytotoxicity. Treatment with 100 μM phyticacid suppressed oxidative stress associated with APP CTF expression, asmeasured by concentrations of hydrogen peroxide in the cell media

Scyllo- and Myo-inositol do not Rescue Cells from Ab-inducedNeurotoxicity

Stereoisomers of cyclohexanehexol-(the parent compound of phytic acid)protect primary cultured neurons from Ab oligomer-induced cytotoxicityand prevent/reverse Alzheimer phenotype in a mouse model {McLaurin, 2006#103}, {McLaurin, 2000 #104}. To test the specific of phytic acid'seffects on Mc65 cells, cells were treated with the cyclohexanehexolisomers scyllo and myo-inositol at doses of 10 μM (a dose that rescuesNGF-differentiated PC12 cells from Ab-induced neurotoxicity) {McLaurin,2000 #104} and 100 mM (the EC₅₀ of phytic acid). Neither isomer rescuedMC65 cells from APP CTF-induced cytotoxicity.

In Vivo Test Results

Applicant also submits Table 1 and FIGS. 4-6 showing data from in vivotesting of the subject matter compounds in Alzheimer's transgenic mice.These Alzheimer's transgenic mice are genetically altered to produceAbeta plaque, and were treated for about six months with compounds ofthe Applicant's invention. Namely, the drinking water was infused withphytic acid so that the final concentration of phytic acid in thedrinking water was 2%.

After six months, the animals were put down for autopsy and necropsy sothat Abeta plaque in the brains was assayed, separated and weighed.

There was no toxicity from the phytic acid in the treated group, nor anysignificant weight loss.

RESULTS

The production of two different fractions of Abeta plaque insolublespecies was lowered or reduced. One species of soluble Abeta plaque waslowered or reduced. All species tested were lowered or reduced,resulting in a complete in vivo success, without toxicity.

Table 1 is a tabulation of all results. FIGS. 4-6 are graphs comparingthe tested compound in vivo with the control vehicle. In all threecases, there was a reduction in Abeta plaque after treatment with 2%phytic acid, compared to the control vehicle without phytic acid.

Key for Table 1 and FIGS. 4-6

-   Phy=IP6 at 2% phytic acid in mixed liquid drinking water with food-   Veh=Negative control vehicle with laboratory food alone.-   ID numbers=which animal was treated

TABLE 1 AS 1-40 Results AB1-40 AB 1-42 Results AB1-42 ID# Animal # TxGenotype Dilution A Dilution B A B Dilution A Dilution B A B  1 4562 Phyapp 16 200 2320.14 70486.195 2 3200 N/A 880713.806  2 4563 Phy app 16200 2851.523 61486.942 2 3200 N/A 696145.624  3 4575 Phy app 16 200 N/A30256.773 2 3200 N/A 480035.385  4 4586 Phy app 16 200 8.402 38495.306 23200 N/A 705489.347  5 4570 Phy app 16 200 1219.51 64667.238 2 3200 N/A207020.619  6 4631 Phy app 16 200 1425.681 36921.948 2 3200 N/A703352.803  7 4567 Phy app 16 200 356.289 33040.457 2 3200 N/A650661.541  8 4582 Phy app 16 200 571.272 50066.569 2 3200 N/A528179.357  9 4564 Veh app 16 200 13828.275 92831.01 2 3200 N/A1349168.224 10 4559 Veh app 16 200 2819.85 55137.189 2 3200 N/A800295.049 12 4579 Veh app 16 200 19.911 34501.466 2 3200 N/A 772672.85613 4581 Veh app 16 200 148.018 44625.892 2 3200 N/A 983346.715 14 4617Vab app 16 200 1309.039 56358.841 2 3200 N/A 759029.966 15 4675 Veh app16 200 560.149 63099.902 2 3200 N/A 947059.623 16 4622 Veh app 16 2004527.412 62445.043 2 3200 N/A 659260.411 17 4811 C Veh Wt 4 3200 NA N/A2 800 N/A 53327.115 13 4809 C Veh App 4 3200 144.004 1306162.415 2 800N/A 186553.084 19 4824 C Ven Wt 4 3200 N/A N/A 2 800 N/A 90689.325 204811 H Veh Wt 4 800 NIA N/A 2 800 N/A 28596.199 21 4809 H Veh App 4 80091.304 69277.345 2 800 N/A 52953.772 22 4824 H Veh Wt 4 800 N/A N/A 2800 N/A 27824.951 23 4812 C Veh Apo 4 3200 82.825 975775 2 800 N/A193869 24 4812 H Veh App 4 800 48.555 16341 2 800 N/A 78863 11 4561 Veh' wt 16 200 N/A N/A 2 3200 N/A N/A BCA Results [pg]AB1-42/μg Protein[pg]AB1-42/μg Protein ID# Fraction A Fraction B A B A B  1 5889.725519.558 0.39413036 135,665691 N/A 1695.12125  2 4147.397 577.8170.68754522 106.412484 N/A 1208.24694  3 2933.003 227.379 N/A 133.067579N/A 2111.17282  4 4586.985 465.21 0.0018317 84.5660377 N/A 1549.81074  55218.961 491.604 0.2337587 131.570115 N/A 421.198238  6 5967.692 687.4250.23900747 53.710511 N/A 1023.17024  7 6690.816 699.027 0.0535493747.2683674 N/A 930.810313  8 8193.309 604.247 0.06972421 82.8577866 N/A874.111675  9 6840.047 670.862 2.01989192 138.375717 N/A 2011.09651 106917.157 485.928 0.40766028 118.338432 N/A 1717.63674 12 4740.048413.594 0.00420059 83.4186811 N/A 1868.19165 13 3521.983 395.8940.04202689 112.721819 N/A 2483.8665 14 6026.783 545.157 0.21720361103.380936 N/A 1392.31445 15 6633.192 542.265 0.10123433 97.9224217 N/A1746.48857 16 7442.838 723.057 0.60829108 86.3625464 N/A 911.768244 177002.482 567.048 N/A N/A N/A 94.0433879 13 7063.165 524.516 0.020387972490.22416 N/A 317.536708 19 5218.073 394.671 N/A N/A N/A 299.531242 205424.769 488.096 N/A N/A N/A 62.4240312 21 5473.284 354.333 0.01668176195.514798 N/A 149.446346 22 6269.239 525.337 N/A N/A N/A 52.9659076 236814.989 515.843 0.01215336 1891.61237 N/A 375.829467 24 6097.491510.085 0.00790492 32.0370933 N/A 154.613628 11 4062.036 332.112 N/A N/AN/A N/A [pg]AB1-40/μg Protein a b a b Phy 0.23994 Phy 96.88957 Phy N/APhy 1226.706 Veh 0.48579 Veh 105.7887 Veh N/A Veh 1733.051 SE a SE b SEa SE b Phy 0.09056 Phy 12.52249 Phy N/A Phy 169.3871 Vah 0.2683 Veh7.258733 Veh N/A Veh 185.8251

Because of the unexpected finding that phytic acid lowers both solubleand insoluble Amyloid production in Alzheimer's transgenic mice,therefore it is reasonable that phtyic acid will be useful inAmyloidosis an example of a protein aggregating Disease.

Furthermore, because the phytic acid and its related compounds disclosein vitro neuroprotective activity suggesting usefulness in treatment ofAlzheimer's Disease, then it follows that the same compounds will beuseful for treatment of motor neuron disease, or amyotrophic lateralsclerosis (ALS), in which the motor neurons unexplainably die off.

In the foregoing description, certain terms and visual depictions areused to illustrate the preferred embodiment. However, no unnecessarylimitations are to be construed by the terms used or illustrationsdepicted, beyond what is shown in the prior art, since the terms andillustrations are exemplary only, and are not meant to limit the scopeof the present invention.

It is further known that other modifications may be made to the presentinvention, without departing the scope of the invention.

1. (canceled)
 2. (canceled)
 3. A method for the treatment of Alzheimer'sdisease and related amyloid plaque development, attenuating amyloidtoxicity or plaque formation and reduction of amyloid plaque, proteinaggregation and amyloidosis consisting essentially of the steps oforally administering to a patient afflicted with Alzheimer's disease aneffective amount of a compound selected from the group consisting ofphytic acid, a phytate salt, an isomer or hydrolysate of phytic acid ora phytate salt, or a mixture of any combination thereof, beingadministered in an amount from about 0.5 grams to about 18.75 grams perday to effectively attenuate APP CTF-induced neurotoxicity to treatAlzheimer's disease and related amyloid plaque development and reduceamyloid plaque, amyloid plaque protein aggregation and amyloidosis. 4.The method for the treatment of Alzheimer's disease and related amyloidplaque development, attenuating amyloid toxicity or plaque formation andreduction of amyloid plaque, protein aggregation and amyloidosis as inclaim 3 wherein the steps of administering an effective amount of acompound selected from the group consisting of phytic acid, a phytatesalt, an isomer or hydrolysate of phytic acid or a phytate salt, or amixture of any combination thereof, is administered in an amount fromabout 5 grams to about 9 grams per day in a single dose.
 5. The methodfor the treatment of Alzheimer's disease and related amyloid plaquedevelopment, attenuating amyloid toxicity or plaque formation andreduction of amyloid plaque, protein aggregation and amyloidosis as inclaim 3 wherein the steps of administering an effective amount of acompound selected from the group consisting of phytic acid, a phytatesalt, an isomer or hydrolysate of phytic acid or a phytate salt, or amixture of any combination thereof, is administered in an amount fromabout 2 grams to about 18.75 grams per day.
 6. A method for thetreatment of Alzheimer's disease and related amyloid plaque development,attenuating amyloid toxicity or plaque formation and reduction ofamyloid plaque, protein aggregation and amyloidosis comprising the stepsof orally administering to a patient afflicted with Alzheimer's diseasean effective amount of a compound selected from the group consisting ofphytic acid, a phytate salt, an isomer or hydrolysate of phytic acid ora phytate salt, or a mixture of any combination thereof, beingadministered in an amount from about 0.5 grams to about 18.75 grams perday to effectively attenuate APP CTF-induced neurotoxicity to treatAlzheimer's disease and related amyloid plaque development and reduceamyloid plaque, protein aggregation and amyloidosis, wherein said stepof administering an effective amount of said compound is the only stepperformed for treating Alzheimer's disease and related amyloid plaquedevelopment and reduction of amyloid plaque, protein aggregation andamyloidosis.
 7. The method for the treatment of Alzheimer's disease andrelated amyloid plaque development attenuating amyloid toxicity orplaque formation and reduction of amyloid plaque, protein aggregationand amyloidosis as in claim 6 wherein the steps of administering aneffective amount of a compound selected from the group consisting ofphytic acid, a phytate salt, an isomer or hydrolysate of phytic acid ora phytate salt, or a mixture of any combination thereof, is administeredin an amount from about 5 grams to about 9 grams per day in a singledose.
 8. The method for the treatment of Alzheimer's disease and relatedamyloid plaque development attenuating amyloid toxicity or plaqueformation, and reduction of amyloid plaque, protein aggregation andamyloidosis as in claim 6 wherein the steps of administering aneffective amount of a compound selected from the group consisting ofphytic acid, a phytate salt, an isomer or hydrolysate of phytic acid ora phytate salt, or a mixture of any combination thereof, is administeredin an amount from about 2 grams to about 18.75 grams per day.
 9. Themethod of claim 3, wherein said compound is administered to a patient onan empty stomach.
 10. A method for the treatment of protein aggregatingdiseases consisting essentially of the steps of orally administering toa patient afflicted with one or more protein aggregating diseases aneffective amount of a compound selected from the group consisting ofphytic acid, a phytate salt, an isomer or hydrolysate of phytic acid ora phytate salt, or a mixture of any combination thereof beingadministered in an amount from about 0.5 grams to about 18.75 grams perday to effectively treat protein aggregating diseases.
 11. A method forthe prevention of aggregation of beta amyloid proteins consistingessentially of the steps of orally administering to a patient aneffective amount of a compound selected from the group consisting ofphytic acid, a phytate salt, an isomer or hydrolysate or phytic acid ora phytate salt, or a mixture of any combination thereof beingadministered in an amount from about 0.5 grams to about 18.75 grams perday to effectively prevent Alzheimer's Disease.
 12. The method of claim11 wherein the steps of administering an effective amount of a compoundselected from the group consisting of phytic acid, a phytate salt, anisomer or hydrolysate of phytic acid or a phytate salt, or a mixture ofany combination thereof, is administered in an amount from about 5 gramsto about 9 grams per day in a single dose.
 13. The method of claim 11wherein the steps of administering an effective amount of a compoundselected from the group consisting of phytic acid, a phytate salt, anisomer or hydrolysate of phytic acid or a phytate salt, or a mixture ofany combination thereof, is administered in an amount from about 2 gramsto about 18.75 grams per day.
 14. The method of claim 11 wherein saidstep of administering an effective amount of said compound is the onlystep performed for preventing Alzheimer's disease.
 15. The method ofclaim 11, wherein said compound is administered to a patient on an emptystomach.
 16. The method of claim 11, wherein said compound is the onlyactive substance administered.
 17. The method of claim 3, wherein saidcompound is administered in liquid form.
 18. The method of claim 11,wherein said compound is infused into water.
 19. The method of claim 11,wherein said final concentration of said compound in water is 2%.